BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3540385 · Received December 27, 2013

    Report

    Report Number
    1226348-2013-37035
    Event Type
    Injury
    Date Received
    December 27, 2013
    Date of Event
    November 28, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE EDS III WAS VISUALLY INSPECTED AND CONFIRMED THAT THE TUBING HAS COME AWAY FROM THE NEEDLESS PORT. GLUE TRACES WERE NOTED ON THE NEEDLESS PORT AND THE TUBING. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TEST FOR LEAK AND BLOCKAGE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. TRENDS WERE MONITORED AND A CAPA -(B)(4) WAS OPENED. THE (B)(4)HAS BEEN IMPLEMENTED AND ADDITIONAL ACTIONS ARE IN PROCESS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT WE DO NOT USE THERAPY DATES, AS A RESULT TODAY'S DATE WAS USED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT DURING THE CSF DRAINAGE, THE LINE BECAME DISCONNECTED AT THE INFERIOR LEVEL OF THE SAMPLING SITE AND THERE WAS A CSF LEAK. THE LINE WAS RECONNECTED URGENTLY THEN A NEW SYSTEM WAS PLACED. ADDITIONAL INFORMATION FROM THE AFFILIATE STATED THAT AN EXTERNAL DRAINAGE SYSTEM 82-1731 WITH CATHETER 82-1706 WAS PLACED IN THE PATIENT.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: DURING THE CSF DRAINAGE, THE LINE GOT DISCONNECTED AT THE INFERIOR LEVEL OF THE SAMPLING SITE. THERE WAS A CSF LEAK. THE LINE WAS RECONNECTED URGENTLY. THEN A NEW SYSTEM HAS BEEN PLACED. THE DEVICE IS AVAILABLE FOR EVALUATION. THE INCIDENT HAS BEEN REPORTED TO THE (B)(4). 12/20 AFFILIATE RECEIVED ADDITIONAL INFORMATION, WE HAVE RECEIVED FURTHER DETAILS CONCERNING THE INCIDENT (B)(4): ON (B)(6) 2013, AN EXTERNAL DRAINAGE SYSTEM , REF :(B)(4), WAS PLACED ON A PATIENT., WITH A A CATHETER REF :(B)(4). ON (B)(6), DURING CFS DRAINAGE, THE LINE GET DISCONNECTED. A NEW DRAINAGE SYSTEM WAS PLACED ON (B)(6) 2013, LOT NO: CPKBRW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677111 CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPJBW1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention